drugset / Trial / NCT00262002
Study of the Safety and Immune Response of a Meningococcal Vaccine Administered to Healthy Infants
RandomizedParallel-groupOpen-labelPrevention
Summary
The purpose of this study is to evaluate the safety, immunogenicity and induction of immune memory after two or three doses of Novartis (Formerly Chiron) Meningococcal ACWY Conjugate Vaccine administered to healthy infants.
Timeline
- Start
- 2004-09
- Primary completion
- 2005-07
- Completion
- 2006-10
Publications
- Results Snape MD, Perrett KP, Ford KJ, John TM, Pace D, Yu LM, Langley JM, McNeil S, Dull PM, Ceddia F, Anemona A, Halperin SA, Dobson S, Pollard AJ. Immunogenicity of a tetravalent meningococcal glycoconjugate vaccine in infants: a randomized controlled trial. JAMA. 2008 Jan 9;299(2):173-84. doi: 10.1001/jama.2007.29-c.
- Results Perrett KP, Snape MD, Ford KJ, John TM, Yu LM, Langley JM, McNeil S, Dull PM, Ceddia F, Anemona A, Halperin SA, Dobson S, Pollard AJ. Immunogenicity and immune memory of a nonadjuvanted quadrivalent meningococcal glycoconjugate vaccine in infants. Pediatr Infect Dis J. 2009 Mar;28(3):186-93. doi: 10.1097/INF.0b013e31818e037d.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | MenACWY Ad+ | Vaccine | — | Intramuscular |
| Subject | MenACWY Ad- | Vaccine | — | Intramuscular |
| Subject | MenACWY-PS | Vaccine | 0.2 unknown | — |
| Subject | Menjugate | Vaccine | — | Intramuscular |
| Background | DTaP-Hib-IPV | Vaccine | — | Intramuscular |
| Background | Hepatitis B vaccine | Vaccine | — | Intramuscular |
| Background | Measles, Mumps and Rubella vaccine | Vaccine | — | — |
| Background | Prevnar 13 | Vaccine | — | Intramuscular |